Medical electrical lead employing load bearing sleeve

ABSTRACT

A medical electrical lead employs a load bearing sleeve arrangement. A medical electrical lead includes an outer sleeve, having proximal and distal ends, and is formed of a first material. At least one electrical conductor is situated within the outer sleeve and extends between the proximal and distal ends of the outer sleeve. At least one electrode is electrically coupled to the electrical conductor. A load bearing sleeve extends between the proximal and distal ends of the outer sleeve. The load bearing sleeve is formed of a second material different from the first material. The load bearing sleeve offers resistance to axial loading forces applied to the lead. The load bearing sleeve can be coextensive with the outer sleeve or extend along at least the majority of the length of the outer sleeve.

FIELD OF THE INVENTION

The present invention relates generally to implantable leads and, moreparticularly, to a medical electrical lead employing a load bearingsleeve arrangement.

BACKGROUND OF THE INVENTION

Implantation of pacing and defibrillation leads in coronary vessels isbecoming increasingly common as atrial and heart failure therapiesbecome more widely accepted. Implanting and stabilizing such leads inthe coronary sinus, great vein, and the branch veins is critical to theefficacy of these and other therapies. It is often desirable ornecessary to remove leads implanted in cardiac structures, such as thecoronary sinus vasculature, for various reasons. Removal of these leadsis problematic, especially if coil electrodes are employed on the lead.

Presently, there are no widely accepted extraction tools available forthe safe removal of coronary vein leads. Various tools have beendeveloped for removing right ventricular leads and right atrial leads,for example, such as mechanical dissection sheaths, electrocauterysheaths, laser sheaths, and other powered sheaths. Such tools, however,are not suited for use within thin walled vessels. Presently availableextraction tools, for example, can only be safely used to enter theproximal portions of the coronary sinus. The risk of significant damageto the vasculature is very high, which can result in cardiac tamponadeand death. Consequently, physicians are presently limited to usinglocking stylets and simple traction as a means of removing coronary veinleads. Use of traction to remove right and left side leads is known toimpart significant axial forces on the leads. Excessively high levels ofaxial loading imparted to conventional leads during lead extraction canresult in lead damage or destruction.

Various types of coatings applied to the electrodes have also beenconsidered in order to facilitate easier removal of coronary vein leads.Although the extractability characteristics of leads can be improvedusing certain lead coatings, use of such coatings has been found tosignificantly reduce lead stability. For example, coated leaddislodgment rates of 25%–50% have been observed. As such, the gains inlead extractability realizable through use of conventional lead coatingsare achieved at the cost of reduced lead stability.

There is a need in the industry for an improved coronary vein lead thatexhibits improved extractability characteristics. There exists a furtherneed for such a lead that can withstand relatively high axial loadsassociated with right and left side lead extraction. The presentinvention fulfills these and other needs, and provides a number ofadvantages over prior art approaches.

SUMMARY OF THE INVENTION

The present invention is directed to a medical electrical lead employinga load bearing sleeve arrangement. According to one embodiment, amedical electrical lead includes an outer sleeve, having proximal anddistal ends, and is formed of a first material. At least one electricalconductor is situated within the outer sleeve and extends between theproximal and distal ends of the outer sleeve. At least one electrode iselectrically coupled to the electrical conductor. A load bearing sleeveextends between the proximal and distal ends of the outer sleeve. Theload bearing sleeve is formed of a second material different from thefirst material. The load bearing sleeve offers resistance to axialloading forces applied to the lead.

The first material of the outer sleeve is preferably formed from aflexible polymer material, and the second material of the load bearingsleeve is formed from an ultra-high molecular weight polymeric material.By way of example, the first material of the outer sleeve can besilicone or polyurethane, and the second material of the load bearingsleeve can be PTFE or ePTFE.

The load bearing sleeve extends along at least a majority of the lengthof the outer sleeve. The load bearing sleeve can, for example, besubstantially coextensive with the outer sleeve. The load bearing sleevecan be entirely encompassed by the outer insulating sleeve.Alternatively, portions of the load bearing sleeve proximate anelectrode or other transition can emerge from the interior of the leadbody so as to cover the electrode or transition. The load bearing sleevesubmerges into the lead body distal of the electrode/transition inconfigurations in which the lead body extends beyond the subjectelectrode/transition.

The electrical conductor can be configured as a coil conductor, and theload bearing sleeve can be situated within a longitudinally extendingcavity of the coil conductor. The longitudinally extending cavity of theload bearing sleeve in such a configuration defines an open lumen of thelead. The open lumen can be dimensioned to receive a guide wire, asensor, a stylet or other implement or instrument.

In accordance with another embodiment, a medical electrical lead of thepresent invention includes an outer sleeve formed of a first materialand an electrical conductor situated within the outer sleeve whichextends between the proximal and distal ends of the outer sleeve. Atleast one electrode is electrically coupled to the electrical conductor.A load bearing sleeve extends between the proximal and distal ends ofthe outer sleeve. A majority of the length of the load bearing sleeve ispositioned within the outer sleeve. The load bearing sleeve is formed ofa second material having a tensile strength greater than that of thefirst material of the outer sleeve and a tensile elongation less thanthat of the first material. An inner surface of a portion of the loadbearing sleeve extends over an outer surface of the at least oneelectrode, and an outer surface of the load bearing sleeve portion isexposed through a gap in the outer sleeve.

According to another embodiment, a method of implanting a medicalelectrical lead into a cardiac structure of a patient's heart involvesproviding a guiding catheter for longitudinally guiding the lead. Thelead preferably has a construction which incorporates a load bearingsleeve arrangement. The implantation method involves inserting theguiding catheter into a chamber of the patient's heart via an accessvessel. The lead is inserted through the guiding catheter via the openlumen to implant the lead within or on the cardiac structure.

In one approach, the implantation method involves providing a guide wirefor longitudinally guiding the lead. The guide wire is inserted throughthe guiding catheter into the cardiac structure. The lead is insertedthrough the guiding catheter and over the guide wire via the open lumento implant the lead within or on the cardiac structure. According toanother approach, a sensor catheter can be inserted through the openlumen to assist in locating the cardiac structure.

The above summary of the present invention is not intended to describeeach embodiment or every implementation of the present invention.Advantages and attainments, together with a more complete understandingof the invention, will become apparent and appreciated by referring tothe following detailed description and claims taken in conjunction withthe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial sectional view of a human heart and a lead systememploying left and right side leads comprising pacing andcardioversion/defibrillation electrodes;

FIG. 2 is a sectional view of a medical electrical lead employing a loadbearing sleeve arrangement in accordance with an embodiment of thepresent invention;

FIG. 3 is a sectional view of a medical electrical lead employing a loadbearing sleeve arrangement in accordance with another embodiment of thepresent invention;

FIG. 4 is a sectional view of a medical electrical lead employing a loadbearing sleeve arrangement in accordance with a further embodiment ofthe present invention;

FIGS. 5A and 5B are partial sectional views of a medical electrical leademploying a load bearing sleeve arrangement in accordance with yetanother embodiment of the present invention; and

FIG. 6 is a sectional view of a medical electrical lead employing a loadbearing sleeve arrangement in accordance with a further embodiment ofthe present invention.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail hereinbelow. It is to beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the invention isintended to cover all modifications, equivalents, and alternativesfalling within the scope of the invention as defined by the appendedclaims.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

In the following description of the illustrated embodiments, referencesare made to the accompanying drawings which form a part hereof, and inwhich is shown by way of illustration, various embodiments in which theinvention may be practiced. It is to be understood that otherembodiments may be utilized, and structural and functional changes maybe made without departing from the scope of the present invention.

In broad and general terms, the present invention is directed to amedical electrical lead which employs a load bearing sleeve arrangement.More particularly, embodiments of the present invention are directed toa medical electrical lead having an outer insulating sleeve and an innerload bearing sleeve. In certain embodiments, the load bearing sleeveextends along a majority of the outer sleeve length. For example, theload bearing sleeve can be substantially coextensive with the outersleeve of the medical electrical lead. In other embodiments, the loadbearing sleeve can be discontinuous or perforated in certain locations,such as at an electrode location.

The medical electrical lead can be configured such that one or moreelectrodes of the lead are positioned proximate an outer surface of theload bearing sleeve. The lead can also be configured such that one ormore electrodes of the lead are positioned proximate an inner surface ofthe load bearing sleeve. In one configuration, for example, the loadbearing sleeve is positioned between the outer sleeve and a coilconductor of the medical electrical lead.

The load bearing sleeve can be disposed within a medical electrical leadso as to define an open inner lumen of the lead. The open lumen can beused to receive a guide wire for over-the-wire implant procedures. Theopen lumen can also be dimensioned to receive a sensor catheter.According to one configuration, two load bearing sleeves can be used:one that defines an inner lumen of the lead, and a second that issituated between a lead conductor(s) and the outer insulating sleeve ofthe lead. Other configurations are possible, including use of one ormore load bearing sleeves to define one or more lumens of a medicalelectrical lead.

The load bearing sleeve is preferably formed from a material having atensile strength greater than that of the outer insulating sleeve. Forexample, the load bearing sleeve can have a tensile strength greaterthan about 5,500 psi, and the outer insulating sleeve can have a tensilestrength of less than about 5,000 psi. The tensile elongation of theload bearing sleeve is preferably significantly less than that of theouter insulating sleeve. For example, the load bearing sleeve can have atensile elongation of less than 100%, and the outer insulating sleevecan have a tensile elongation of 300%–1000% or more.

The load bearing sleeve is preferably formed from an ultra-highmolecular weight polymeric material, such as PTFE(polytetrafluoroethylene) or ePTFE (expanded polytetrafluoroethylene),for example. The outer insulating sleeve can be formed from materialscommonly used for medical electrical lead, such as silicone orpolyurethane.

A medical electrical lead of the present invention is particularly wellsuited for use with left side pacing and cardioversion/defibrillationdevices, it being understood that advantages of the present inventioncan be realized in right side lead systems. As was discussed brieflyabove, pacing and defibrillation leads implanted in the coronary vesselsare becoming more common as left atrial and left ventricular therapiesbecome more accepted. In the absence of standard extraction tools,relatively high axial loads must typically be applied to such leadsduring lead extraction. The integrity of such a lead fabricated usingconventional techniques can be compromised if the lead is subjected toexcessively high axial forces.

A medical electrical lead fabricated in accordance with the presentinvention advantageously provides for improved axial loadingcharacteristics over conventional leads. Left side leads, for example,can be fabricated to incorporate a load bearing sleeve in a mannerdescribed herein to significantly enhance the extractability performanceof such leads.

An important advantage realized by employing a load bearing sleeve in amedical electrical lead of the present invention concerns a significantimprovement in axial loading characteristics as compared to manyconventional designs. It is appreciated in the art that right sidedleads generally require high axial loads for extraction. Left sidedleads require substantially lower axial loads for extraction, but aresmaller and more flexible than right sided leads, typically resulting ingenerally less robust designs. In accordance with the principles of thepresent invention, improved axial loading characteristics are achievedfor right sided leads, while inclusion of a load bearing sleeve in leftsided leads provides additional robustness to such implementations.

Referring to FIG. 1 of the drawings, there is shown one embodiment of animplantable medical device which includes a cardiac function management(CFM) device 100 electrically and physically coupled to an intracardiaclead system 102. The intracardiac lead system 102 is implanted in ahuman body with portions of the intracardiac lead system 102 insertedinto a heart 101. The intracardiac lead system 102 is used to detect andanalyze electric cardiac signals produced by the heart 101 and toprovide electrical energy to the heart 101 under certain predeterminedconditions to treat cardiac arrhythmias.

The intracardiac lead system 102 includes one or more electrodes usedfor pacing, sensing, or defibrillation. In the particular embodimentshown in FIG. 1, the intracardiac lead system 102 includes a rightventricular lead system 104, a right atrial lead system 105, and a leftatrial/ventricular lead system 106. In one embodiment, the rightventricular lead system 104 is configured as an integrated bipolarpace/shock lead. One, some, or all of the lead systems shown in FIG. 1can be configured to include a load bearing sleeve arrangement of thepresent invention.

It is understood that the implantable medical device shown in FIG. 1 canemploy a single lead for use in a single heart chamber or multiple heartchambers. It is also understood that a medical electrical lead of thepresent invention can incorporate one or more electrodes, including oneor more of a pacing electrode, cardioversion/defibrillation electrode,and monitoring electrode, for example.

The right ventricular lead system 104 includes an SVC-coil 116, anRV-coil 114, and an RV-tip electrode 112. The RV-coil 114, which mayalternatively be configured as an RV-ring electrode, is spaced apartfrom the RV-tip electrode 112, which is a pacing electrode for the rightventricle.

The right atrial lead system 105 includes an RA-tip electrode 156 and anRA-ring electrode 154. The RA-tip 156 and RA-ring 154 electrodes mayprovide respectively pacing pulses to the right atrium of the heart anddetect cardiac signals from the right atrium. In one configuration, theright atrial lead system 105 is configured as a J-lead.

In this configuration, the intracardiac lead system 102 is shownpositioned within the heart 101, with the right ventricular lead system104 extending through the right atrium 120 and into the right ventricle118. In particular, the RV-tip electrode 112 and RV-coil electrode 114are positioned at appropriate locations within the right ventricle 118.The SVC-coil 116 is positioned at an appropriate location within theright atrium chamber 120 of the heart 101 or a major vein leading to theright atrium chamber 120 of the heart 101. The RV-coil 114 and SVC-coil116 depicted in FIG. 1 are defibrillation electrodes.

An LV-tip electrode 113 and an LV-ring electrode 117 are insertedthrough the coronary venous system and positioned adjacent to the leftventricle 124 of the heart 101. The LV-ring electrode 117 is spacedapart from the LV-tip electrode 113, which is a pacing electrode for theleft ventricle. Both the LV-tip 113 and LV-ring 117 electrodes may alsobe used for sensing the left ventricle providing two sensing siteswithin the left ventricle. The left atrial/left ventricular lead system106 further includes an LA-tip 136 and LA-ring 134 electrode positionedadjacent to the left atrium 122 for pacing and sensing the left atrium122 of the heart 101.

The left atrial/left ventricular lead system 106 includes endocardialpacing leads that are advanced through the superior vena cava (SVC), theright atrium 120, the valve of the coronary sinus, and the coronarysinus 150 to locate the LA-tip 136, LA-ring 134, LV-tip 113 and LV-ring117 electrodes at appropriate locations adjacent to the left atrium andventricle 122, 124, respectively. In one example, leftatrial/ventricular lead placement involves creating an opening in apercutaneous access vessel, such as the left subclavian or left cephalicvein. The left atrial/left ventricular lead 106 is guided into the rightatrium 120 of the heart via the superior vena cava.

From the right atrium 120, the left atrial/left ventricular lead system106 is deployed into the coronary sinus ostium, the opening of thecoronary sinus 150. The lead system 106 is guided through the coronarysinus 150 to a coronary vein of the left ventricle 124. This vein isused as an access pathway for leads to reach the surfaces of the leftatrium 122 and the left ventricle 124 which are not directly accessiblefrom the right side of the heart. Lead placement for the leftatrial/left ventricular lead system 106 may be achieved via thesubclavian vein access and a preformed guiding catheter for insertion ofthe LV and LA electrodes 113, 117, 136, 134 adjacent the left ventricle124 and left atrium 122, respectively. In one configuration, the leftatrial/left ventricular lead system 106 is implemented as a single-passlead.

The lead system further includes a terminal end for establishingphysical and electrical connection with a connector block of the CFMdevice 100. The CFM device can be configured as, or incorporatefunctions of, a pacemaker, cardioverter, defibrillator, cardiac monitor,re-synchronizer or a device that incorporates the functions of two ormore of these devices.

Turning now to FIG. 2, there is illustrated a sectional view of amedical electrical lead which incorporates a load bearing sleevearrangement in accordance with an embodiment of the present invention.The sectional view of FIG. 2 is taken at a region of the lead whichencompasses an electrode. The electrode is generally representative of adefibrillation electrode or a pacing electrode, such as aplatinum/iridium electrode, and the electrical conductor thatelectrically connects with the electrode is generally representative ofa coil conductor, such as a single or multiple filar coil conductor, ora cable. It is understood that other electrode and conductorconfigurations can be employed in a medical electrical lead of thepresent invention, and that the particular configurations shown anddescribed herein are intended to be non-limiting illustrative examples.

According to the embodiment illustrated in FIG. 2, the medicalelectrical lead includes an outer insulating sleeve 202, which can beformed from a conventional material suitable for implantable leads. Byway of example, the insulating sleeve 202 can be fabricated fromsilicone, polyurethane, or other biocompatible, flexible material. Anelectrode 204 is shown positioned in a gap formed between adjacentsections 202A, 202B of the outer sleeve 202. The interfaces between theelectrode 204 and respective outer sleeve sections 202A, 202B can besealed using conventional techniques.

In FIG. 2, the electrode 204 is representative of acardioversion/defibrillation electrode. Appropriate electricalconnections are made between the electrode 204 and the electricalconductor 208 of the lead. By way of example, electrical connectionsthat breach the load bearing sleeve, such as some crimping and swagingoperations, in isolated areas may be used.

In the illustrative embodiment of FIG. 2, a load bearing sleeve 206 isshown disposed within the lead, such that all of the load bearing sleeve206 is surrounded by the outer insulating sleeve 202. In otherembodiments, some of which are described below, most of the load bearingsleeve 206 is surrounded by the outer insulating sleeve 202, but one ormore sections of the load bearing sleeve 206 can emerge from theinterior of the lead body at particular locations, such as at electrodeor transition locations.

The lead, according to this configuration, includes a central lumenwithin which a coil conductor 208 is situated. Although a single lumenis shown for simplicity, it is understood that a medical electrical leadof the present invention can include two, three, or more lumens.Moreover, it is understood that a lead of the preset invention caninclude one or more open lumens, closed lumens, or a combination of openand closed lumens. Such lumens can be dimensioned to receive steeringtendons, a guide wire, finishing wire, sensor, instrument, or other typeof catheter, for example. A lumen can also be dimensioned to receive astylet, although the load bearing sleeve arrangement of the presentinvention can obviate the need for a conventional stylet in manyapplications. A lumen of such a lead can be provided with a lubricioussleeve or coating, such as a PTFE or ePTFE sleeve, for example.

In the configuration shown in FIG. 2, the load bearing sleeve 206 isdisposed entirely within the lead (i.e., encompassed by the outer sleeve202) and extends along the length of the lead or some majority portionof the lead. As shown, the load bearing sleeve 206 is positioned withinthe lead lumen, it being understood that the specific location of theload bearing sleeve 206 within the lead structure can be varied.

In this configuration, the coil conductor 208 is positioned within theload bearing sleeve 206. The hollow coil conductor may thus define aninner lumen of the lead, which can be an open or closed lumen. In aconfiguration in which a solid (i.e., non-hollow) conductor is employed,such as a cable, no such inner lumen would be defined within the loadbearing sleeve 206 depicted in FIG. 2. However, it can be appreciatedthat the load bearing sleeve 206 can be dimensioned to receive a solidelectrical conductor along with one or more other elements, such as asensor catheter for example. Such a sensor catheter can incorporate apressure sensor, an oxygen sensor or a temperature sensor, for example.

In the case of an over-the-wire lead configuration, by way of example,the load bearing sleeve 206 is dimensioned to receive a hollow coilconductor 208. The coil conductor 208 is dimensioned to receive a guidewire suitable for left heart chamber over-the-wire lead implantprocedures, for example. The coil conductor 208 is preferably providedwith a lubricious sleeve, liner, or coating. In one configuration, thecoil conductor 208 can be provided with a lubricous load bearing sleeve,in addition to, or exclusive of, the load bearing sleeve 206. An exampleof one such variation in configuration will be described below withreference to FIG. 6.

The lubricious material provided within the coil conductor 208preferably has a low-energy surface that inhibits platelet adhesion. Asuitable lubricious material that provides a low-energy surface for thisusage is ePTFE. Such a surface advantageously provides for enhancedtactile feedback to the physician during use of the over-the-wire leadarrangement.

As was discussed previously, the load bearing sleeve 206 is preferablyformed from a material having a tensile strength greater than that ofthe outer insulating sleeve 202. According to one configuration, theload bearing sleeve 206 has a tensile strength greater than about 5,500psi, and the outer insulating sleeve 202 has a tensile strength of lessthan about 5,000 psi. The tensile elongation of the load bearing sleeve206 is preferably less than 100%, and that of the outer insulatingsleeve is preferably 300%–1000% or more. In general, the load bearingsleeve 206 can have a wall thickness ranging between about 0.001 inchesand about 0.01 inches. According to one particular configuration, theload bearing sleeve 206 has a wall thickness ranging between about 0.002inches and about 0.006 inches.

The load bearing sleeve 206 is preferably formed from an ultra-highmolecular weight polymeric material, such as PTFE or ePTFE, for example.It has been determined that leads with substantial amounts of exposedePTFE have demonstrated high rates of dislodgment. Extensive use ofePTFE within the interior of a medical electrical lead, rather than onthe exterior, provides for a more robust lead implementation, which canwithstand higher levels of axial loading without adversely affectingperformance as compared to conventional leads.

The electrical characteristics of a medical electrical lead of thepresent invention can be selectively altered by judicious selection ofthe electrode/load bearing sleeve configuration. By way of example,variations in electrode surface exposure and coverage can be achieved byimplementing designs in which the electrode is fully exposed (i.e., notcovered by the load bearing sleeve), entirely covered by the loadbearing sleeve, or partially covered by the load bearing sleeve.

Varying the level of electrode exposure/coverage can result in varyingseveral electrical characteristics of the lead electrodes, such as thepolarization characteristics of the lead electrodes. Moreover, differentcurrent distributions can be achieved by selectively altering the levelof electrode exposure/coverage. In some configurations, an increase inimpedance may result, but enhancements in other mechanical or electricalcharacteristics, such as electrode polarization and/or currentdistribution, can offset such increases in impedance.

FIG. 3 illustrates another embodiment of a medical electrical lead whichemploys a load bearing sleeve arrangement 306 in accordance with theprinciples of the present invention. According to this embodiment, thelead includes an outer insulating sleeve 302 and an electrode 304situated within a gap formed between adjacent sections 302A, 302B of theouter sleeve 302. In this particular configuration, a load bearingsleeve 306 is discontinuous at the region proximate the electrode 304.For example, the load bearing sleeve 306 can be formed to have adiscontinuity at each of the electrodes 304 that are situated along thelength of the lead.

As shown, electrode 304 is situated within a gap formed between adjacentsections 306A, 306B of the load bearing sleeve 306. The electrode 304 isconnected to the electrical conductor 308, which can be a coil conductorfor example, and protrudes through the load bearing sleeve 306 and theouter insulating sleeve 302. In a typical configuration, the electrode304 is generally flush with respect to the outer surface of the outerinsulating sleeve 302. A suitable sealing material or arrangement isemployed between the electrode 304 and the adjacent outer sleevesections 302A, 302B and load bearing sleeve sections 306A, 306B,respectively.

The embodiment of a medical electrical lead shown in FIG. 4 is similarto that shown in FIG. 3, in that the load bearing sleeve arrangement 406includes a discontinuity at a location proximate the electrode 404. Inthis embodiment, an electrically conductive element, material, or filler410 is employed at an interface between the electrode 404 and theelectrical conductor 408. The filler or element 410 provides forconduction of electrical current between the electrode 404 and conductor408, and can be sized to provide a desired outer surface profile of thelead. The element 410 can, if desired, be implemented to intimatelyconnect with adjacent edges of adjacent load bearing sleeve sections406A, 406B, such as through use of known mechanical or chemical/adhesionmeans.

FIGS. 5A and 5B illustrate variations of another embodiment of thepresent invention. According to this embodiment, a load bearing sleeve506 is positioned within the lead such that most of the load bearingsleeve 506 is encompassed by an outer insulating sleeve 502. In a regionproximate an electrode 510, however, the load bearing sleeve 506 emergesfrom the interior of the lead body so as to extend over the electrode510. The load bearing sleeve 506 returns to the sub-surface of the leadbody after passing the distal end of the electrode 510. In aconfiguration in which the lead body does not extend beyond theelectrode, as in the case of a tip electrode for example, the loadbearing sleeve need not return to the lead body sub-surface.

In the embodiment of FIGS. 5A and 5B, the load bearing sleeve 506 is notsevered at the region proximate the electrode 510, but remainscontinuous along its length. In the variation shown in FIG. 5B, theexposed portion of the load bearing sleeve 506A covering the electrode510 can include perforations.

It is noted that the bent or bulged section of the load bearing sleeve506 proximate the electrode 510 can be pre-formed or formed at the timeof lead fabrication. It is further noted that the wall thickness of thebent or bulged section of the load bearing sleeve 506 proximate theelectrode 510 can be different from that of other sections of the loadbearing sleeve 506. For example, the thickness of the load bearingsleeve wall in the bent or bulged region can be less than that of thenon-bent portions of the load bearing sleeve 506, such as by up to about50% less in thickness.

The embodiment shown in FIGS. 5A and 5B provides the desired improvementin axial loading characteristics while not adversely contributing toimplant instability and lead dislodgment. It is known that ePTFE, forexample, is a material that prevents or inhibits tissue in-growth (e.g.,fibrotic encapsulation or any other form of cellular adhesion). As wasdiscussed above, extensive use of ePTFE as an outer sleeve of animplantable medical electrical lead has been associated with high leaddislodgment rates. However, limiting the external use of ePTFE primarilyat the electrode regions of a medical electrical lead in accordance withthe principles of the present invention avoids such lead dislodgmentproblems and provides for significantly improved axial loadingcharacteristics.

A further embodiment of a medical electrical lead implemented inaccordance with the present invention is depicted in FIG. 6. Accordingto this embodiment, the load bearing sleeve 606 is disposed within alumen defined within the interior of a coil electrode 608. The coilelectrode 608, in this configuration, is situated between the innersurface of the outer insulating sleeve 602 and the outer surface of theload bearing sleeve 606. The electrode 604 is shown positioned in a gapformed between adjacent sections 602A, 602B of the outer sleeve 602, andelectrically connects with the coil electrode 608.

In this configuration, the load bearing sleeve 606 defines an innerlumen of the medical electrical lead. This configuration is particularlywell-suited for use in over-the-wire implantation procedures, as theinterior surface of the load bearing sleeve 606 preferably defines alubricious surface. In an alternative configuration, a second loadbearing sleeve can be situated between the coil conductor 608 and theouter insulating sleeve 602 in a manner previously discussed.

A medical electrical lead incorporating a load bearing sleeve inaccordance with the principles of the present invention can be used in avariety of medical procedures. By way of example, a method of implantinga medical electrical lead into a cardiac structure of a patient's heartinvolves use of a guiding catheter for longitudinally guiding the lead.The lead has an open lumen and includes an outer sleeve formed of afirst material. A coil conductor is situated within the outer sleeve andextends between proximal and distal ends of the outer sleeve. At leastone electrode is electrically coupled to the coil conductor. The leadfurther includes a load bearing sleeve that extends between the proximaland distal ends of the outer sleeve. The load bearing sleeve is formedof a second material different from the first material. The load bearingsleeve offers resistance to axial loading forces applied to the lead.

The procedure involves inserting the guiding catheter into a chamber ofthe patient's heart via an access vessel. The procedure further involvesinserting the lead through the guiding catheter via the open lumen toimplant the lead within or on the cardiac structure.

According to one procedure, a guide wire is provided for longitudinallyguiding the lead. The procedure involves inserting the guide wirethrough the guiding catheter into the cardiac structure. The lead isinserted through the guiding catheter and over the guide wire via theopen lumen to implant the lead within or on the cardiac structure.

In another procedure, a sensor catheter is provided. The procedureinvolves inserting the sensor catheter through the open lumen to assistin locating the cardiac structure. The cardiac structure can be acardiac vessel, such as a left side coronary vessel, for example. Theseand other procedures can be performed using a medical electrical leadhaving improved axial load characteristics in accordance with theprinciples of the present invention.

A medical electrical lead of the present invention may also beconfigured to include a lead stabilization mechanism in combination witha load bearing sleeve arrangement. A lead stabilization mechanism,according to one embodiment, employs an adhesion site or sites atstrategic locations on the lead, including electrically active and/orelectrically inactive locations of the lead. A polymer outer sleeve orcoating of the lead provides for improved lead extractability, while theadhesion sites provide for increased stability at selected locations ofthe lead.

The lead, according to this embodiment, has a sleeve arrangement whichincludes one or more adhesion sites provided at one or more of the firstlead locations. The adhesion sites promote tissue in-growth orattachment between the adhesion sites and cardiac tissue contacting theadhesion sites to enhance stabilization of the implantable lead. Thecardiac tissue may represent tissue of a cardiac structure of the heartor coronary vasculature of the heart.

The adhesion sites, in one embodiment, define apertures in the sleeve atone or more first locations of the sleeve. For example, the adhesionsites may comprise exposed portions of one or more of the electrodes orother exposed portions of the lead's insulation or covering. Accordingto another embodiment, the adhesion sites include a structure having aporous surface that promotes cardiac tissue in-growth or attachment atthe adhesion sites. For example, a metallic annular structure may bedisposed at the adhesion site. A metallic ring, for example, havingporous surface characteristics may be employed to promote cellularadhesion at the adhesion site. The annular structure may incorporate anelectrode, sensor or drug delivery arrangement. An annular electrodestructure, for example, may incorporate a sensing, pacing or shockingelectrode.

In accordance with a further embodiment, the adhesion sites comprise amaterial that promotes cardiac tissue in-growth or attachment at theadhesion sites. For example, the first material may comprise a firstpolymer material that substantially prevents tissue in-growth betweenthe first locations and cardiac tissue contacting the first locations.The adhesion sites, in contrast, comprise a second polymer material thatpromotes tissue in-growth or attachment between the adhesion sites andcardiac tissue contacting the adhesion sites. The second polymermaterial may, for example, have a porosity, pore sizes or distributionof pore sizes that differ from that of the first polymer material. Byway of further example, the second polymer material may differ in termsof hydrophobicity relative to the first polymer material.

In one embodiment, the first material comprises a first type of PTFE,and a second material of the adhesion sites comprises a second type ofPTFE. In one particular arrangement, the first type of PTFE comprises afirst type of ePTFE, and the second type of PTFE comprises a second typeof ePTFE. The second type of ePTFE preferably differs from the firsttype of ePTFE in terms of one or more of porosity, pore sizes ordistribution of pore sizes.

A suitable lead stabilization system and method that can be used incombination with a load bearing sleeve arrangement as described hereinis disclosed in commonly owned, copending U.S. Ser. No. 10/004,708,filed Dec. 4, 2001, which is hereby incorporated herein by reference.

It will, of course, be understood that various modifications andadditions can be made to the preferred embodiments discussed hereinabovewithout departing from the scope of the present invention. Accordingly,the scope of the present invention should not be limited by theparticular embodiments described above, but should be defined only bythe claims set forth below and equivalents thereof.

1. A medical electrical lead, comprising: an outer sleeve formed of afirst material comprising a flexible polymer material, the outer sleevehaving a proximal end and a distal end; an electrical conductor situatedwithin the outer sleeve and extending between the proximal and distalends of the outer sleeve; at least one electrode electrically coupled tothe electrical conductor; and a load bearing sleeve extending betweenthe proximal and distal ends of the outer sleeve, the load bearingsleeve formed of a second material different from the first material,the second material comprising an ultra-high molecular weight polymericmaterial, the load bearing sleeve offering resistance to axial loadingforces applied to the lead.
 2. The lead of claim 1, wherein the loadbearing sleeve extends along at least a majority of a length of theouter sleeve.
 3. The lead of claim 1, wherein the load bearing sleeve issubstantially coextensive with the outer sleeve.
 4. The lead of claim 1,wherein the load bearing sleeve is situated between the outer sleeve andthe electrical conductor.
 5. The lead of claim 4, wherein an outersurface of the electrode is situated at an exposed portion of the outersleeve, and an inner surface of the electrode contacts an electrodeinterface surface of the load be,aring sleeve, such that the electrodeis electrically coupled to the electrical conductor through theelectrode interface surface.
 6. The lead of claim 4, wherein an outersurface of the electrode is situated at an exposed portion of the outersleeve, and an inner surface of the electrode is electrically coupled tothe electrical conductor via a gap in a surface of the load bearingsleeve.
 7. The lead of claim 6, further comprising an electricallyconductive filler or element provided within the gap.
 8. The lead ofclaim 1, wherein the electrode is situated within a gap in the outersleeve and a portion of the load bearing sleeve protrudes through thegap so as to extend over an outer surface of the electrode, such that aninner surface of the electrode is electrically coupled to the electricalconductor.
 9. The lead of claim 8, wherein the second material of theload bearing sleeve comprises a biocompatible material.
 10. The lead ofclaim 1, wherein the electrical conductor comprises a coil conductor,and the load bearing sleeve is situated within a longitudinallyextending cavity of the coil conductor.
 11. The lead of claim 10,wherein the longitudinally extending cavity of the load bearing sleevedefines an open lumen of the lead.
 12. The lead of claim 11, wherein theopen lumen is dimensioned for receiving a guide wire.
 13. The lead ofclaim 11, wherein the open lumen is dimensioned for receiving a sensorcatheter.
 14. The lead of claim 1, wherein the electrical conductorcomprises a coil conductor, and the load bearing sleeve is situatedwithin a longitudinally extending cavity of the coil conductor, themedical electrical lead further comprising a second load bearing sleevesituated between the outer sleeve and the coil conductor.
 15. The leadof claim 1, wherein the ultra-high molecular weight polymeric materialcomprises PTFE or ePTFE.
 16. The lead of claim 1, wherein the firstmaterial of the outer sleeve comprises silicone or polyurethane, and thesecond material of the load bearing sleeve comprises PTFE or ePTFE. 17.The lead of claim 1, wherein the first material of the outer sleeve hasa tensile strength of less than about 5,000 psi, and the second materialof the load bearing sleeve has a tensile strength greater than about5,500 psi.
 18. The lead of claim 1, wherein the first material of theouter sleeve exhibits a tensile elongation of greater than about 300%,and the second material of the load bearing sleeve exhibits a tensileelongation of less than about 100%.
 19. The lead of claim 1, wherein theload bearing sleeve has a wall thickness ranging between about 0.001inches and about 0.01 inches.
 20. The lead of claim 1, wherein the loadbearing sleeve has a wall thickness ranging between about 0.002 inchesand about 0.006 inches.
 21. The lead of claim 1, wherein the leadcomprises a plurality of lumens.
 22. The lead of claim 1, wherein theelectrical conductor comprises a cable or a wire.
 23. A medicalelectrical lead, comprising: an outer sleeve formed of a first materialcomprising a flexible polymer material, the outer sleeve having aproximal end and a distal end; an electrical conductor situated withinthe outer sleeve and extending between the proximal and distal ends ofthe outer sleeve; at least one electrode electrically coupled to theelectrical conductor; and a load bearing sleeve extending between theproximal and distal ends of the outer sleeve, a majority of a length ofthe load bearing sleeve positioned within the outer sleeve, the loadbearing sleeve formed of a second material having a tensile strengthgreater than that of the first material and a tensile elongation lessthan that of the first material, the second material comprising anultra-high molecular weight polymeric material, an inner surface of aportion of the load bearing sleeve extending over an outer surface ofthe at least one electrode, and an outer surface of the load bearingsleeve portion exposed through a gap in the outer sleeve.
 24. The leadof claim 23, wherein the load bearing sleeve is substantiallycoextensive with the outer sleeve.
 25. The lead of claim 23, wherein theload bearing sleeve is situated between the outer sleeve and theelectrical conductor.
 26. The lead of claim 23, wherein the electricalconductor comprises a coil conductor.
 27. The lead of claim 23, whereinthe electrical conductor comprises a cable or wire.
 28. The lead ofclaim 23, wherein the ultra-high molecular weight polymeric materialcomprises PTFE or ePTFE.
 29. The lead of claim 23, wherein the firstmaterial of the outer sleeve comprises silicone or polyurethane, and thesecond material of the load bearing sleeve comprises PTFE or ePTFE. 30.The lead of claim 23, wherein the first material of the outer sleeve hasa tensile strength of less then about 5,000 psi, and the second materialof the load bearing sleeve has a tensile strength greater than about5,500 psi.
 31. The lead of claim 23, wherein the first material of theouter sleeve exhibits a tensile elongation of greater than about 300%,and the second material of the load bearing sleeve exhibits a tensileelongation of less than about 100%.
 32. The lead of claim 23, whereinthe load bearing sleeve has a wall thickness ranging between about 0.001inches and about 0.01 inches.
 33. The lead of claim 23, wherein the loadbearing sleeve has a wall thickness ranging between about 0.002 inchesand about 0.006 inches.
 34. The lead of claim 23, wherein the leadcomprises a plurality of lumens.
 35. A method of implanting a medicalelectrical lead into a cardiac structure of a patient's heart,comprising: providing a guiding catheter for longitudinally guiding thelead, the lead having an open lumen and comprising: an outer sleeveformed of a first material comprising a flexible polymer material, theouter sleeve having a proximal end and a distal end; an electricalconductor situated within the outer sleeve and extending between theproximal and distal ends of the outer sleeve; at least one electrodeelectrically coupled to the electrical conductor; and a load bearingsleeve extending between the proximal and distal ends of the outersleeve, the load bearing sleeve formed of a second material differentfrom the first material, the second material comprising an ultra-highmolecular weight polymeric material, the load bearing sleeve offeringresistance to axial loading forces applied to the lead; inserting theguiding catheter into a chamber of the patient's heart via an accessvessel; and inserting the lead through the guiding catheter via the openlumen to implant the lead within or on the cardiac structure.
 36. Themethod of claim 35, further comprising: providing a guide wire forlongitudinally guiding the lead; inserting the guide wire through theguiding catheter into the cardiac structure; and inserting the leadthrough the guiding catheter and over the guide wire via the open lumento implant the lead within or on the cardiac structure.
 37. The methodof claim 35, further comprising: providing a sensor catheter; insertingthe sensor catheter through the open lumen to assist in locating thecardiac structure.
 38. The method of claim 35, wherein the cardiacstructure comprises a cardiac vessel.
 39. The method of claim 35,wherein the load bearing sleeve extends along at least a majority of alength of the outer sleeve.
 40. The method of claim 35, wherein the loadbearing sleeve is substantially coextensive with the outer sleeve. 41.The method of claim 35, wherein the load bearing sleeve is situatedbetween the outer sleeve and the electrical conductor.
 42. The method ofclaim 35, wherein the electrode is situated within a gap in the outersleeve and a portion of the load bearing sleeve protrudes through thegap so as to extend over an outer surface of the electrode, such that aninner surface of the electrode is electrically coupled to the electricalconductor.
 43. The method of claim 35, wherein the load bearing sleeveis situated within a longitudinally extending cavity of the electricalconductor and defines the open lumen of the lead.
 44. The method ofclaim 35, wherein the ultra-high molecular weight polymeric materialcomprises PTFE or ePTFE.
 45. The method of claim 35, wherein the firstmaterial of the outer sleeve comprises silicone or polyurethane, and theload bearing sleeve comprises PTFE or ePTFE.
 46. The method of claim 35,wherein the first material of the outer sleeve has a tensile strength ofless than about 5,000 psi, and the load bearing sleeve has a tensilestrength of greater than about 5,500 psi.
 47. The method of claim 35,wherein the first material of the outer sleeve exhibits a tensileelongation of greater than about 300%, and the load bearing sleeveexhibits a tensile elongation of less than about 100%.
 48. A medicalelectrical lead, comprising: an outer sleeve formed of a first materialcomprising a flexible polymer material, the outer sleeve having aproximal end and a distal end, the outer sleeve comprising: one or morefirst locations comprising a third material that substantially preventstissue in-growth between the first locations and cardiac tissuecontacting the first locations; and one or more adhesion sites providedat the one or more first locations, the adhesion sites promoting tissuein-growth or attachment between the adhesion sites and cardiac tissuecontacting the adhesion sites; an electrical conductor situated withinthe outer sleeve and extending between the proximal and distal ends ofthe outer sleeve; at least one electrode electrically coupled to theelectrical conductor; and a load bearing sleeve extending between theproximal and distal ends of the outer sleeve, the load bearing sleeveformed of a second material differing from the first material, thesecond material comprising an ultra-high molecular weight polymericmaterial, the load bearing sleeve offering resistance to axial loadingforces applied to the lead.
 49. The lead of claim 48, wherein theadhesion sites define apertures in the outer sleeve at the one or morefirst locations of the outer sleeve.
 50. The lead of claim 48, whereinthe adhesion sites comprise a material that promotes cardiac tissuein-growth or attachment at the adhesion sites.
 51. The lead of claim 48,wherein the adhesion sites comprise exposed portions of the at least oneelectrode.
 52. The lead of claim 48, wherein the adhesion sites comprisea structure having a porous surface that promotes cardiac tissuein-growth or attachment at the adhesion sites.
 53. The lead of claim 48,wherein the third material comprises a first polymer material thatsubstantially prevents tissue in-growth between the first locations andcardiac tissue contacting the first locations, and the adhesion sitescomprise a fourth polymer material that promotes tissue in-growth orattachment between the adhesion sites and cardiac tissue contacting theadhesion sites.
 54. The lead of claim 53, wherein the fourth polymermaterial has a porosity differing from that of the third polymermaterial.
 55. The lead of claim 53, wherein the fourth polymer materialhas an average pore size differing from that of the third polymermaterial.
 56. The lead of claim 53, wherein the fourth polymer materialhas a distribution of pore sizes differing from that of the thirdpolymer material.
 57. The lead of claim 53, wherein the fourth polymermaterial has a hydrophobicity differing from that of the third polymermaterial.
 58. The lead of claim 48, wherein the second and thirdmaterials comprise ePTFE.